Blockage of the nasal passages is obviously an inconvenience to persons who experience it. Blockage of the nasal passages is particularly uncomfortable at night, since it can lead to sleep disturbances, sleep irregularities, and/or snoring. In addition, a person with such a condition may wake often because he/she is not inhaling sufficient quantities of oxygen.
While there is a small portion of the human population which has some type of malformation of the nasal passages, such as a deviated septum, the majority of people who experience blockage of the nasal passages usually are suffering from the nasal congestion and other symptoms associated with the common cold and/or allergies. The common cold, although not usually a serious illness, is a highly prevalent, discomforting and annoying affliction. The term "common cold" is applied to minor respiratory illnesses caused by a variety of different respiratory viruses, of which rhinoviruses are the major known cause of common colds, accounting for approximately 50 percent of the colds in adults.
With the common cold, symptoms of nasal discharge, nasal congestion/blockage, and sneezing usually commence on the first day of illness and progress to maximum severity by the second or third day. Other symptoms may include mild burning of the eyes, loss of smell and taste, a feeling of pressure or fullness in the sinuses, sinus pain, headache, and vocal impairment. Many of these symptoms are shared by sufferers of allergies.
At present, treatment for the nasal congestion/blockage, sinus discomfort and pain, and other cold symptoms, including fever and the general malaise associated therewith, generally contain an analgesic (aspirin or acetaminophen) and one or more antihistamines, decongestants, cough suppressants, antitussives and expectorants; the majority of these drugs are taken orally. Other specific pharmaceutical actives for nasal symptoms (e.g., congestion) generally contain either oxymetazoline or phenylephrine and are generally delivered topically to the nasal mucosa via a nasal spray.
Nasal delivery of therapeutic agents has been well known for a number of years.
See, for example, U.S. Pat. No. 4,749,700 to Wenig, issued Jun. 7, 1988, U.S. Pat. No. 4,778,810 to Wenig, et al., issued Oct. 18, 1988 and U.S. Pat. No. 4,729,997 to Wenig issued Mar. 8, 1988. Nasal saline sprays have been used to moisturize nasal passages and to dissolve build-up in the nasal mucosa; however, saline solutions alone have not proved satisfactory for relief of nasal congestion. Menthol has been administered orally from lozenges and the like, as well as delivered to the nasal mucosa from an inhaler, see for example, Clinical Otolaryngology, 1988, vol. 13, pp. 25-29. Yet menthol delivered in such a manner has not been found to provide a sufficient level of relief.
Another method of relieving the sinus pain, and other cold symptoms described above, is by application of heat to the nose and/or sinus areas. Such heat treatments include the use of hot towels and reusable thermal packs containing water and/or microwaveable gels. In general, such devices, which require the thermal source to be replenished, are inconvenient to use. Further, many of these thermal units or devices do not provide long lasting heat or maintain a consistent temperature over long periods of time. The beneficial therapeutic effects from this administration of heat diminishes after the heat source is removed; therefore, it is desirable to provide a sustained heat source to the afflicted area for as long as possible, preferably for about eight hours. These devices are also inconvenient to use at night, when the treatment is most often needed. Further, these thermal devices do little to aide breathing through the nose due to nasal congestion/blockage.
Nasal dilators for aiding breathing through the nose are known, however, these devices are also not generally effective in relieving nasal congestion/blockage, sinus discomfort and pain, and other cold/allergy symptoms. U.S. Pat. No. 4,414,977, issued to Rezakhany, discloses one such nasal dilator. The nasal dilator includes generally elongated top and bottom rings which are spaced apart and connected together by a rear strut and a front strut. The front strut is longer than the rear strut and includes a bend therein formed at a position close to the front end of the bottom ring. When in place in the nasal passage, the top ring fits in the nasal valve within the nostril to prevent the tissue from being drawn in during inhalation, and to reduce extra flow resistance during exhalation. The bottom ring fits above the entrance to the nostril and serves to stabilize the position of the top ring within the nasal passage. One of these nasal dilators must be inserted into each nasal passage to provide unobstructed breathing. These nasal dilators, however, are not always effective since they are uncomfortable to wear, may cause irritation and itching of the nostril, unsafe to use at night during sleep, and are inconvenient to use when the wearer has nasal drainage due to a cold.
Another nasal dilator is disclosed in U.S. Pat. No. 1,292,083, issued to Sawyer. This nasal dilator includes pads of adhesive material to which are attached metal loops. The pads are applied to the exterior surface of the nose above the nostrils. Once the pads are affixed, a dilating member is connected with each of the loops. The dilating member consists of a metal wire that provides a spring force which is directed outward or upward when hooked ends of the dilating member are engaged with the loops of the pads. A further nasal dilator is disclosed in U.S. Pat. No. 1,950,839, issued to Chirila. This nasal dilator is similar to that of Sawyer but employs suction cups to secure a dilating member to the exterior surface of the nose. These dilators are not always effective because the dilating members can easily become disengaged from the pads or suction cups that secure the dilating members to the exterior of the nose, which could cause injury to the face or eyes, particularly during sleep.
Other nasal dilators are disclosed in U.S. Pat. No. 5,533,499, issued to Johnson, U.S. Pat. No. 5,533,503, issued to Doubek, et al., and U.S. Pat. No. 5,546,929, issued to Muchin. These nasal dilators comprise a truss comprising a flexible strip and spring member which traverses the bridge of the nose. The flexible strip adheres to the exterior surface of the nose such that the ends of the truss member stabilize the outer wall of the nostrils, thereby preventing the outer wall from drawing in during breathing.
While the above described nasal dilators may aid breathing through the nose in a healthy person, it is evident that there is a continuing need for an improved means of treating the nasal congestion/blockage, sinus discomfort and pain, and other cold/allergy symptoms associated therewith. For example, Cronk, et al. have disclosed in U.S. Pat. No. 5,706,800, a nasal dilator which includes an aromatic medication or transdermal medication disposed on the dilator. Unfortunately, these devices are not completely effective, and therefore, a need for a nasal dilator that can provide safe and effective relief of these symptoms still exists. Moreover, there still is a need for a nasal dilator that can be reliably worn at night when the nasal congestion/blockage problem is most acute and most uncomfortable. In addition, there still is a need for a nasal dilator that can be reliably worn through extended therapeutic periods without discomfort to the wearer. The nasal dilator should also be of efficient design and relatively uncomplicated.
The inventors of the present invention have developed a nasal dilator which comprises a means for dilating congested and/or blocked nasal passages due to the common cold and/or allergies and at least one thermal element to relieve the sinus discomfort and pain, and other cold/allergy symptoms associated therewith, which can be safely and comfortably worn, day or night, on the nose of a human for an extended period of time. The present inventors have also discovered a method of treatment for relief of the nasal congestion/blockage, sinus discomfort and pain, and other cold/allergy symptoms associated therewith, by applying said nasal dilator to the nose of a human in need of such treatment.
It is therefore an object of the present invention to provide a nasal dilator which comprises a means for dilating the nostrils and at least one thermal element which can be safely and comfortably worn, day or night, on the nose of a human for an extended period of time.
It is also an object of the present invention to provide a method of treatment for relief of the nasal congestion/blockage, sinus discomfort and pain, and other cold symptoms associated therewith, by applying said nasal dilator to the nose of a human in need of such treatment.
It is a further object of the present invention to provide a method of treatment for relief of the nasal congestion/blockage, sinus discomfort and pain, sneezing, and other symptoms associated with allergies, by applying said nasal dilator to the nose of a human in need of such treatment.
These objectives and additional objectives will become readily apparent from the detailed description which follows.